Key-person risk in ATMP manufacturing

Advanced therapy medicinal products are made under the EU GMP rules written for them, with short shelf lives and small batches. Release cannot wait, so every step that depends on one person sits on the critical path.

Where does dependency concentrate in ATMP manufacturing?

• QP certification. Release waits for the one Qualified Person who knows the product, even when all results are in.
• Traceability. Times of batch-record steps are written or typed by hand, then checked by someone else.
• Environmental monitoring. Results are transcribed by hand from instruments and plates.
• Change control. Impact assessments wait for the few people who understand the process well enough to write them.
• Deviations. Investigations queue behind the same specialists.

Which KPIs does the screening use for ATMPs?

• QP release lag: days from the last required QC result to QP certification.
• Traceability event gap: share of batch-record steps whose time is written or typed by hand instead of recorded by a system.
• Deviation closure time: average calendar days from opening a deviation to QA approval of the closed investigation.
• Manual environmental records: share of environmental monitoring results transcribed by hand instead of captured by an instrument interface or barcode.
• Change control approval time: days from change initiation to QA approval of the impact assessment and implementation plan.

If you do not have a figure, the screening uses the industry median.

What does the audit look at in ATMP manufacturing?

The workshop walks one batch from material receipt to certification and asks who has to be present at each step. Required GMP steps, such as QP certification itself, do not raise the score; waiting for one particular person to do them does.

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